safety and immunogenicity study of two doses of an inactivated h5n1 influenza vaccine (whole virion, vero cell derived)

Conditions: Influenza

Summary: the objectives of this phase i/ii study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted h5n1 influenza vaccine in a healthy young adult population. subjects will be randomized 1:1 to receive two intramuscular injections (21 days apart) of the vaccine containing either 3.75 µg or 7.5 µg h5n1 hemagglutinin (ha) antigen in a non-adjuvanted formulation. subjects will be monitored for safety and for antibody response to the vaccine. a data safety monitoring board will review the safety data after the first and second vaccination.


Eligibility criteria:
inclusion criteria: * are 21 to 45 years of age, inclusive, on the day of screening * have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry * are clinically healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination * are physically and mentally capable of participating in the study * agree to keep a daily record of symptoms for the duration of the study * if female and capable of bearing children, have a negative urine pregnancy test result within 24 hours of the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study. exclusion criteria: * have a history of exposure to h5n1 virus or a history of vaccination with an h5n1 influenza virus * are at high risk of contracting h5n1 influenza infection (e.g. poultry workers) * suffer from or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder * suffer from any inherited or acquired immunodeficiency * test positive for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) * suffer from a disease or are undergoing a form of treatment that can be expected to influence immune response. such treatment includes, but is not limited to, systemic or high dose inhaled (\>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs * have a history of inflammatory or degenerative neurological disease (e.g. guillain barré syndrome) * have a history of severe allergic reactions or anaphylaxis * have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating * have received a blood transfusion or immunoglobulins within 90 days of study entry * have donated blood or plasma within 30 days of study entry * have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study * have undergone systemic corticoid therapy within 30 days prior to study entry * have a functional or surgical asplenia * have a known or suspected problem with alcohol or drug abuse * were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product * are a member of the team conducting this study or are in a dependent relationship with the study investigator. dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site conducting the study * if female: are pregnant or lactating

Keywords: pandemic influenza